Quality Assurance Officer FSP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Discover Impactful Work:

We are seeking a Quality Assurance Officerto support our government customer on site inSilver Spring Maryland. This is a per diem non benefited role initially starting at 6 hours per week and increasing to 13 hours per week in 2026.

• Relocation assistance is NOT provided for this role.
• Must be a U.S. citizen
• Must be able to pass a comprehensive background check whichincludes a drug screening and a physical.
• Must be able to pass a NACI for Common Access Card.

A day in the Life:

Responsible for all onsite Clinical Trial activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Facilitate quality assurance monitoring by study sponsors. Relies on experience and judgment to plan and accomplish goals and tasks. Performs a variety of tasks. May lead and direct the work of others.

Description Of Responsibilities:

• Responsible for daily Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activities
• Conducts audits and reviews/analyzes data and documentation. This includes internal audits such as the laboratory.
• Assist in compiling and reviewing reports
• Develop maintain and assess long term quality assurance programs
• Collect and utilize data to inform long term quality assurance programming
• Develop and implement corrective actions assess efficacy of corrective actions
• Develops maintains and ensures compliance with Standard Operating Procedures (SOPs) be knowledgeable and compliant with all Human Subjects Protection FDA and current Good Clinical Practice (GCPs) regulations as well as ensuring all contractor study personnel remain trained and up to date in their respective fields.
• Facilitate quality assurance monitoring by study sponsors.
• Relying on experience and judgment to plan and accomplish goals and tasks.
• Prepares and maintains instructions and pre-established guidelines to perform the functions of the job.
• Coordinates with entire Clinical Trials Center (CTC) team to ensure compliance for all studies regardless of study phase.
• Ensures successful completion of all internal and external audits assists Clinical Research Coordinator (CRC) with regulatory compliance maintains staff credentials provides Quality Control of all source documents conducts chart review and updates SOPs as necessary.
• Prepares monthly status report and performs a variety of tasks. May lead/direct the work of others.
• Other duties as assigned by Supervisor.

Keys to Success:

Required Education & Experience

• Must have a Bachelors degree. Masters degree is preferred.
• Minimum of five (5) years of experience in quality assurance for clinical trials with expertise in ICH/GCP compliance.
• Certification in quality management (e.g. ASQ or equivalent) is required.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Unclear Seniority